Measurements of Angulation of the C-spine

Comparison of Measurements of the Cervical Spine in Adults With and Without Immobilisation

This is a prospective study aiming to assess the shape of the neck in adults. In addition the study will look at the shape of the neck in a spinal collar and the comfort while wearing a spinal collar.

Study Overview

• Status: Completed
• Conditions: Cervical Spine
• Intervention / Treatment: Device: spinal collar

Detailed Description

The investigators aim to compare baseline scans of the neck in those aged 18yrs and older to a second neck scan where the participant is wearing a spinal collar. Experts will analyse the scans for measurements of angulations. In addition the study will collect demographic data and results from a validated patient questionnaire assessing comfort wearing the spinal collar.

The hypothesis:

1. The shape of the neck is different when comparing the young and old populations
2. The spinal collar does not alter the shape of the spine
3. The spinal collars are uncomfortable in the elderly population

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W2 1NY
    • Imperial College Healthcare NHS Trust
  • London, United Kingdom, NW8 9LE
    • The Wellington Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Persons aged 18yrs and over to those aged 30yrs
2. Persons aged 70yrs and over
3. Ability to give informed consent to participate in the study

Exclusion Criteria:

1. Persons under 18yrs of age and those aged 31yrs -69yrs
2. Persons who lack capacity to consent for entry into the study
3. Persons who are unable to complete the visual analogue score or questionnaire due to co-existent visual and hearing loss. Severe hearing impairment will be defined as unable to hear the researcher with hearing aids if required. Severe visual impairment will be defined as being unable to read the patient information sheet even with visual aids.
4. Persons unable to understand the information leaflet in English.
5. Those with current neck pain, known previous C-spine injury or known medical condition affecting the spine.
6. Persons who do not pass the safety questionnaire to undergo an MRI scan
7. Persons who are unable to tolerate an MRI scan due to claustrophobia
8. Persons who are unable to transfer to the scanner table independently
9. Persons unable to lie flat and still for 10 minutes
10. Persons who do not give consent to their General Practitioner being informed of scan results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Spinal collar; Participants will undergo MRI scans in and out a spinal collar to assess whether the measurements of angulation of the C-spine change whilst wearing a spinal collar.	Device: spinal collar; cervical collar to immobilise the cervical spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurements of Angulation of the Neck (C-spine) on MRI Scans	Comparison of the measurements of angulation of the neck (assessed on MRI imaging) in the young person compared to the older person. Statistical analysis to allow comparison of groups.	Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Degree of Change in Measurements of Angulation of the Neck (C-spine) on MRI Scans Whilst Wearing a Spinal Collar Compared to When Not Wearing a Spinal Collar.	Comparison of the degree of change of measurements of angulation of the neck from MRI scans of a young persons neck (C-spine) in and out of a spinal collar to those of an older persons neck (C-spine) in and out of a spinal collar on MRI imaging. Statistical analysis to allow comparison of groups.	Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Comfort in and Out of a Spinal Collar.	Comfort after one hour of wearing a spinal collar measured by the 'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable)	Baseline, approximately 30 minutes and after wearing a collar for one hour

Collaborators and Investigators

• Sponsor: Imperial College Healthcare NHS Trust
• Collaborators: Imperial College London; The Wellington Hospital, London
• Investigators: Principal Investigator: Michael Fertleman, Imperial College Healthcare NHS Trust/ The Wellington Hospital, London

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2019
• Primary Completion (Actual): June 2, 2019
• Study Completion (Actual): June 2, 2019

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Cervical spine
• Other Study ID Numbers: 18SM4805; 19/SC/0059 (Other Identifier: Health Research Authority, Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No